Found (248) clinical trials

A national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in women and men with HR+, HER2-negative advanced or metastatic breast cancer

The BOLERO-2 study demonstrated an enormous benefit for patients who received everolimus in addition to exemestane in patients who progressed during/after a non steroidal (NSAI), which led to approval of everolimus in this indication. However, experience from routine use report a high rate of intolerability of this innovative treatment approach ...

The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 g and QMF149 150/320 g via Concept1) over two respective MF doses (MF 400 g and MF 800 g via Twisthaler (total daily dose)) in poorly controlled asthmatic patients as ...

This randomized, observer-blind, placebo-controlled multicenter, Phase 3 study will be conducted at multiple sites. The composition of the Quadrivalent VLP Influenza Vaccine to be used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs for the 2018-2019 influenza virus strains. Approximately ...

Currently, axillary surgery for breast cancer is considered as staging procedure that does not seem to influence breast cancer mortality, since the risk of developing metastasis depends mainly on the biological behaviour of the primary (seed-and-soil model). Based on this, the postsurgical therapy should be considered on the basis of ...

To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma

The main purpose of this study is evaluation of deep molecular response (MR4.5; BCR-ABL IS < 0.0032%) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase CML. Via the use of MR4.5 EUTOS ('European Treatment and Outcome Study for CML') laboratories adequate and reliable molecular ...

This study aims to assess the optimal duration of nilotinib 300 mg BID consolidation treatment, in order that patients remain in treatment-free remission (MR4.0) 12 months after starting the Treatment-Free Remission (TFR) phase of the study. Rationale CP-CML patients who have received 2 or more calendar years of first-line imatinib ...